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MicroScan Pos Combo Panel Type 31

by Beckman Coulter Inc. United States EUDAMED

Ref B1016-139

EMDN W0203010192

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-PartNumberB1016-139XT Basic UDI-DIDate21 Jun 2022RegisteredStatusActive
European UnionCE/IVDD NumberB-PartNumberB1016-139XT Basic UDI-DIDate21 Jun 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
MicroScan Pos MIC/Combo Panel Family
Model / Reference
B1016-139
Primary DI / UDI-DI
D-PartNumberB1016-139XT, 15099590656416
Basic UDI-DI
B-PartNumberB1016-139XT, 15099501MCOVPOSSN
Unit of Use DI
05099590656419
EMDN Code
W0203010192, W0203010185
Device Class
Class IVD General
Class B
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000010288
Authorised representative
Beckman Coulter Ireland Inc. IE-AR-000000886

Other devices from Beckman Coulter, Inc.

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Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues NoEUDAMEDYesEUDAMED
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 7c6dd95b-fa34-4c82-a8fa-9aeafeb13022 61 fields · synced 22 Oct 2026
  • EUDAMED 85465520-ac61-45cb-8f63-5962b2e7fb6d 61 fields · synced 18 May 2026